Sanofi, GSK begin human trial of coronavirus vaccine candidate

Paris: Pharmaceutical giants Sanofi and Glaxo Smith Kline (GSK) on Thursday started a clinical trial for their jointly developed Covid-19 vaccine candidate.

A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the US, the two drugmakers said.

The vaccine candidate uses the same recombinant protein-based technology as one of Sanofi's seasonal influenza vaccines with GSK's pandemic adjuvant technology.

The Phase 1/2 clinical trial is a randomised, double blind and placebo-controlled trial designed to evaluate the safety, tolerability and immune response of the Covid-19 vaccine candidate.

The companies anticipate first results early December which will support the initiation of a Phase 3 trial in the same month.

If data are sufficient for licensure application, the plan is to request regulatory approval in the first half of 2021, French pharma company Sanofi and its British peer GSK said, adding that the two companies are scaling up manufacturing of the antigen and adjuvant with the target of producing up to one billion doses in 2021.